CN1200729C - 干扰素阴道给药片及制备工艺 - Google Patents
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Abstract
本发明提供了一种干扰素阴道给药片，用于治疗妇女慢性宫颈炎、宫颈糜烂、病毒性阴道炎等多种妇科疾病。本发明还提供了制备干扰素阴道片的工艺方法。该干扰素阴道给药片，具有稳定性高、疗效显著、制备工艺简单、使用后无不溶性固体颗粒、无砂砾感等优点。
Description
技术领域
本发明涉及干扰素阴道给药片及制备工艺。
技术背景
干扰素是一种广谱抗病毒抗肿瘤的生物制品，它对于多种病毒性疾病具有良好的治疗效果，例如：病毒性肝炎、带状疱疹等。此外，研究表明妇女宫颈炎的发病与HSV和HPV-16型感染密切相关。目前市场上的干扰素制剂产品有针剂、栓剂、滴眼液和凝胶四种。但到目前为止尚无一种可供阴道给药的干扰素片剂面市，并应用于治疗妇女慢性宫颈炎、宫颈糜烂、病毒性阴道炎等妇科疾病。
干扰素是一种活性蛋白，它对光、热、酸碱度、化学物质等都非常敏感，极易造成失活或影响干扰素的活性检测，将干扰素制备为片剂时，其组方中都须加入粘合剂、崩解剂及润滑剂等辅料。而这些物质中很多将造成这种影响，因此筛选出对制备干扰素片剂无影响的辅料及辅料的用量组合对于能否制成可供使用的药品至为关键。
公开号1140088A《白细胞干扰素口含片及其制法》、公开号CN1227124A《β干扰素含片及其制备方法》、公开号CN1227125A《复方α干扰素含片及其制备方法》描述的都是关于干扰素口含片的制备方法，而且以上三个专利中所采用的辅料都涉及淀粉，并将之作为赋形剂使用，因此这些片剂在溶解过程中有大量的不溶物甚至颗粒，并有沙砾感，仅作为口服给药是可以接受的，但作为阴道给药是不行的。
另外，公开号：CN1105849A《硬质多孔松泡体栓及其制造工艺》描述的是一种可用于制备干扰素栓的工艺方法。但其工艺复杂、生产周期长、生产设备要求高，批生产量小。
发明内容
本发明的目的在于提供一种干扰素阴道给药片剂，这种片剂具有一定的硬度，能够保证产品在运输过程中不破碎：具有很好的溶解崩散性质，能够在阴道中体液的作用下崩散溶胀并释放药物，无沙砾感，并具有一定润滑效果。
本发明的另一个目的是制备干扰素阴道给药片剂的工艺方法。
为了实现本发明的目的，本发明的干扰素阴道给药片剂，在组方设计中除主药干扰素和硬脂酸镁(颗粒润滑剂，用量极少)外，其它辅料均为可溶或可溶胀的甘露醇、羟丙基纤维素、碳酸氢钠、酒石酸(或柠檬酸或己二酸)、羟丙甲纤维素、羧甲基淀粉钠、硼酸和聚维酮等。所述的干扰素可以是任何天然或重组干扰素。
本发明的干扰素阴道给药片剂，其特征还在于其组方中还可加入碳酸氢钠和酒石酸(或柠檬酸或己二酸)等，制成泡腾片剂。根据上述组方，本发明主药和辅料的配比(重量比)为：
干扰素 0.5×108～30×108IU
甘露醇 400～900g
羟丙纤维素 50～450g
碳酸氢钠 0～70g
酒石酸(或柠檬酸或己二酸) 0～60g
硼酸 3～100g
硬脂酸镁 5～30g
4％羟丙甲纤维素水溶液 200～400g
15％聚维酮无水乙醇溶液 0～30g
羧甲基淀粉钠 5～150g
制成 1000片
本发明的干扰素阴道给药片剂其制备工艺方法：
(1)制备可溶胀性颗粒：取羟丙纤维素和甘露醇混合，加入羟丙甲纤维素水溶液，制粒、通风干燥后即得。
(2)干混合：将可溶胀性颗粒与主药及其它辅料混合。
(3)压片包衣。
在以上所述工艺方法加入泡腾颗粒(碱性包裹颗粒和酸性包裹颗粒的合称)，还可制备成干扰素泡腾片。本发明提供的干扰素阴道给药片，具有稳定性高、使用后证明无不溶性固体颗粒、无砂砾感等优点，而且制备工艺方法容易操作。
具体实施方式
按照本发明提供的上述组方和其制备工艺方法，提供以下实施例：
实施例一：
1.处方
干扰素 1.5×108IU
甘露醇 640g
羟丙纤维素 320g
羧甲基淀粉钠 10.4g
硼酸 60g
液体石蜡 3g
硬脂酸镁 15g
4％羟丙甲纤维素水溶液 300g
制成 1000粒
2.制备
①制备可溶胀性颗粒
按处方用量称取羟丙纤维素和甘露醇置快速搅拌制粒机的物料锅内，密闭锅盖，开机混合2-3分钟，关机，加入4％羟丙甲纤维素水溶液，开动搅拌机和切割绞刀8-10分钟，至颗粒成形后停机。
将颗粒装，于60℃通风干燥1-2小时，再升温至75℃干燥，干颗粒干燥失重控制在1-2％之间。
②干混合
取可溶胀性干燥颗粒适量过60目筛，细粉(6-8倍于液体石蜡的重量)倒入液体石蜡，混匀，再过60目筛，将过筛后的石蜡细粉，混入颗粒，再与颗粒一起过14目筛，使全部颗粒成为均匀的小于14目筛以下的小颗粒。
将全批量的干扰素、硼酸等一起倒入混合机内，开机混合10分钟，取出，装入密闭容器内。
③压片包衣
实施例二：
1.处方
干扰素 1.5×108IU
甘露醇 700g
羟丙纤维素 100g
碳酸氢钠 35g
酒石酸 28g
硼酸 7g
硬脂酸镁 18g
4％羟丙甲纤维素水溶液 300g
15％聚维酮无水乙醇溶液 9g
羧甲基淀粉钠 100g
制成 1000片
2.制备
①制备可溶(胀)性颗粒：
取甘露醇700g，羟丙纤维素100g混合均匀，加入4％羟丙甲纤维素溶液300g(±20％)，搅拌均匀，过16目筛制成颗粒，70℃干燥。
②制备碱性包裹颗粒：取碳酸氢钠35g，加入15％聚维酮乙醇溶液6g，搅拌均匀，过18目筛，70℃干燥，干后颗粒、粉碎过80目筛。
③制备酸性包裹颗粒：取酒石酸28g，加入15％聚维酮乙醇溶液3g，搅拌均匀，过18目筛，70℃干燥，干后颗粒过80目筛。
④干混合：将干扰素、羧甲淀粉钠、硼酸、硬脂酸镁、可溶胀性颗粒、碱性包裹颗粒、酸性包裹颗粒混合均匀。
⑤压片包衣。
Claims (4)
1.一种干扰素阴道给药片，它包含干扰素和具水溶性和水溶胀性药用辅料，其特征在于：所述的干扰素，可以是天然干扰素，也可以是重组干扰素，所述的辅料除硬脂酸镁外，选自水溶性和吸水溶胀性的甘露醇、羧甲基淀粉钠、羟丙纤维素、碳酸氢钠、酒石酸、羟丙甲纤维素、聚维酮和硼酸。
2.如权利要求1所述的一种干扰素阴道给药片，其制备方法特征在于包括：
(1)首先制备可溶胀性颗粒：取羟丙纤维素和甘露醇混合，加入羟丙甲纤维素水溶液，制粒、通风干燥后即得；
(2)干混合：将可溶胀性颗粒与主药干扰素及其它辅料按处方量混合；
(3)压片包衣。
3.如权利要求1所述的干扰素阴道给药片，其特征还在于其主药和辅料的配比(重量比)为：
干扰素 0.5×108～30×108IU
甘露醇 400～900g
羟丙纤维素 50～450g
碳酸氢钠 0～70g
酒石酸(或柠檬酸或己二酸) 0～60g
硼酸 3～100g
硬脂酸镁 5～30g
4％羟丙甲纤维素水溶液 200～400g
15％聚维酮无水乙醇溶液 0～30g
羧甲基淀粉钠 5～150g
制成 1000片
4.如权利要求2所述的干扰素阴道给药片的制备方法，其特征还在于包括：
(1)将水溶性和水溶胀性辅料混合后，制备可溶胀性颗粒：
(2)制备酸性包裹颗粒：取酒石酸或柠檬酸，加入聚维酮乙醇溶液，搅拌均匀，过筛制粒，干燥即得；制备碱性包裹颗粒：取碳酸氢钠，加入聚维酮乙醇溶液，搅拌均匀，过筛制粒，干燥即得：
(3)将主药干扰素与可溶胀性颗粒、酸性包裹颗粒、碱性包裹颗粒及其它辅料干混合；
(4)在常温条件下直接压片后，包衣。
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| IT202000025885A1 (it) * | 2020-10-30 | 2022-04-30 | Vacutest Kima S R L | Composizione conservante per urine, dispositivo per il campionamento di urine e metodo per la produzione di un dispositivo per il campionamento di urine |
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